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Regulatory Affairs Strategist for Pharmaceutical Product Development

1 month ago

North Sydney Council, Australia Novo Nordisk Full time

About the Role

We are seeking an experienced Regulatory Affairs Strategist to join our team in Australia and New Zealand. This is a critical role that requires strong leadership skills, regulatory expertise, and a passion for driving product development and commercialization.

Key Responsibilities

  • Lead regulatory affairs activities for assigned products, ensuring compliance with Australian and New Zealand regulations.
  • Develop and implement regulatory strategies to support product development, registration, and commercialization.
  • Manage the preparation, compilation, and submission of regulatory documentation, including new product registrations, variations, renewals, and responses to queries.
  • Serve as the primary liaison with regulatory authorities, maintaining positive relationships and monitoring developments in the regulatory landscape.
  • Collaborate with cross-functional teams and stakeholders to provide regulatory guidance throughout the product lifecycle.
  • Maintain accurate regulatory records for assigned products and participate in audits to ensure compliance with regulatory standards.

Requirements

  • Bachelor's degree in a scientific discipline or a related field.
  • A minimum of 5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry, with significant expertise in Australian regulatory requirements.
  • Demonstrated proficiency in leading regulatory affairs strategies, preparation and submission of regulatory documentation, regulatory affairs intelligence, and the development and approval of product labelling.
  • Strong competency in stakeholder management, comprehensive business and industry knowledge, adaptability in dynamic environments, effective execution, and impactful communication.
  • Must be an Australian Citizen or Permanent Resident.

What We Offer

  • An estimated salary of $120,000 - $150,000 per annum, depending on experience.
  • The opportunity to work with a leading life-science company that is passionate about improving people's lives.
  • A dynamic and supportive work environment that encourages collaboration and innovation.